Dapagliflozin AND Metformin Hydrochloride · Regulatory approval

FDA approval: Dapagliflozin AND Metformin Hydrochloride

U.S. Food and Drug Administration · April 6, 2026

Regulatory Update Why this matters to you Expert discussion

An action by a regulator. Authoritative on labelling and availability.

AI Summary

The FDA approved a fixed-dose combination tablet of dapagliflozin and metformin hydrochloride on 6 April 2026, available in four strength combinations. This is a regulatory action record that documents approval of the formulation and does not contain clinical trial results, efficacy comparisons, or safety data.

What was studied

Regulatory approval. Intervention: Dapagliflozin and metformin hydrochloride fixed-dose combination tablets, extended release, oral formulations in four strengths.

Key findings

Four extended-release tablet formulations approved: dapagliflozin 5 mg + metformin 500 mg, dapagliflozin 10 mg + metformin 500 mg, dapagliflozin 5 mg + metformin 1 gram, dapagliflozin 10 mg + metformin 1 gram

Safety

This record does not contain clinical trial results, efficacy data, or safety comparisons.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

FDA approval of a fixed-dose combination of dapagliflozin and metformin; this is a regulatory action, not a clinical evidence report, and does not contain trial outcomes or comparative efficacy data.

Study design

As stated by the source record.

InterventionDapagliflozin and metformin hydrochloride fixed-dose combination tablets, extended release, oral formulations in four strengths

Reported figures

Quoted from the source exactly as published.

Approval date2026-04-06

Application typeANDA (Abbreviated New Drug Application)

SponsorMSN

Caveats

This record does not contain clinical trial results, efficacy data, or safety comparisons.
No patient population, study design, or outcome measures are reported.
Approval is based on bioequivalence or other regulatory criteria; efficacy claims cannot be inferred from this record alone.
No information on indication, contraindications, or prescribing guidance is provided in this approval notice.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

insufficient

This is a regulatory record, not a clinical study.

Directness

insufficient

Record describes approval action only; no clinical outcome data reported.

Consistency

insufficient

No efficacy or safety comparisons presented in this record.

Risk of bias

insufficient

Regulatory approval record does not include clinical trial methodology.

Sample adequacy

insufficient

No trial sample size or population data reported in this approval record.

Source abstract

Drugs@FDA record for application ANDA211479. This is a regulatory action record, not a clinical study. Brand name: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE. Active ingredient: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE. Sponsor: MSN. Submission type: ORIG (original application). Approval status date: 2026-04-06. Products: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE, TABLET, EXTENDED RELEASE, ORAL, DAPAGLIFLOZIN 10MG + METFORMIN HYDROCHLORIDE 500MG; DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE, TABLET, EXTENDED RELEASE, ORAL, DAPAGLIFLOZIN 5MG + METFORMIN HYDROCHLORIDE 500MG; DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE, TABLET, EXTENDED RELEASE, ORAL, DAPAGLIFLOZIN 10MG + METFORMIN HYDROCHLORIDE 1GM; DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE, TABLET, EXTENDED RELEASE, ORAL, DAPAGLIFLOZIN 5MG + METFORMIN HYDROCHLORIDE 1GM.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Dapagliflozin AND Metformin HydrochlorideMSN